510(k) K830355

SECURA IV VOLUMETRIC INFUSION PUMP by Diatek, Inc. — Product Code FRN

K830355 is an FDA 510(k) premarket notification submitted by Diatek, Inc. for the device "SECURA IV VOLUMETRIC INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on March 1, 1983. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Diatek, Inc. has at least 10 other 510(k) clearances on record.